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510(k) K254208

FLOWRUNNER Aspiration System by Expanse Medical, Inc. — Product Code QEZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2026
Date Received
December 29, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Aspiration Thrombectomy Catheter
Device Class
Class II
Regulation Number
870.5150
Review Panel
CV
Submission Type

To remove thrombus from the peripheral and/or coronary vasculature through aspiration.

Other clearances by Expanse Medical, Inc.

  • K251488 — FLOWRUNNER Aspiration System (July 14, 2025)
  • K234073 — ICE Aspiration System (April 19, 2024)

Other clearances for product code QEZ

  • K253925 — Aventus Thrombectomy System (January 15, 2026)
  • K252509 — AlphaVac Multipurpose Mechanical Aspiration System F1885 (November 24, 2025)
  • K251312 — Vesalio Peripheral System (October 24, 2025)
  • K251488 — FLOWRUNNER Aspiration System (July 14, 2025)
  • K243549 — JETi Hydrodynamic Thrombectomy System (April 4, 2025)
  • K250013 — VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP (March 24, 2025)
  • K240397 — AlphaVac MMA F1885 System (H787253020) (April 1, 2024)
  • K232458 — JETi™Hydrodynamic Thrombectomy System (December 19, 2023)
  • K213388 — AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System (April 4, 2022)
  • K213565 — JETi AIO Peripheral Thrombectomy System (February 1, 2022)